EP1520171A2 - Differenciation automatique d'une solution a examiner et d'une solution temoin - Google Patents

Differenciation automatique d'une solution a examiner et d'une solution temoin

Info

Publication number
EP1520171A2
EP1520171A2 EP03761487A EP03761487A EP1520171A2 EP 1520171 A2 EP1520171 A2 EP 1520171A2 EP 03761487 A EP03761487 A EP 03761487A EP 03761487 A EP03761487 A EP 03761487A EP 1520171 A2 EP1520171 A2 EP 1520171A2
Authority
EP
European Patent Office
Prior art keywords
control
liquid
control liquid
dye
sample
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP03761487A
Other languages
German (de)
English (en)
Inventor
Guenter Frey
Carina Horn
Otto Gaa
Hans Kintzig
Hans-Ruediger Murawski
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Original Assignee
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by F Hoffmann La Roche AG, Roche Diagnostics GmbH filed Critical F Hoffmann La Roche AG
Publication of EP1520171A2 publication Critical patent/EP1520171A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/96—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood or serum control standard
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/104165—Lipid, cholesterol, or triglyceride standard or control
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/104998—Glucose, ketone, nitrate standard or control
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
    • Y10T436/106664—Blood serum or blood plasma standard or control
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/25—Chemistry: analytical and immunological testing including sample preparation

Definitions

  • the invention relates to a method for automatically distinguishing between a sample liquid and a control liquid, in particular in connection with analytical measuring systems.
  • the invention further relates to corresponding control liquids suitable for the new method.
  • test strips have been established for the reliable, fast and uncomplicated analysis of body fluids, especially blood and urine.
  • Simple test strips permit the visual determination of the concentration of the analyte of interest, for example by changing the color of a reagent layer on the test strip and comparing it with a color scale, which in turn correlates analyte concentrations.
  • Measuring systems that contain both test strips and measuring devices are more convenient. These systems record - mostly photometrically or electrochemically - the changes that result from the reaction of the analyte with the reagents contained on or in the test strip.
  • test strips cannot be produced in 100% identical batches, it is necessary to carry out batch-specific calibrations of the measuring devices.
  • this is preferably done automatically using batch-specific codes which are read in by the measuring device or entered into the measuring device by the user and which lead to an automatic adaptation of a measured value evaluation algorithm.
  • both test strips and measuring devices are subject to fluctuations in their measuring accuracy and reliability, which can be caused, for example, by long or improper storage of the test strips or can arise with measuring devices due to use. Therefore it is necessary lent to carry out a functional and quality control of the measuring system at regular intervals in order to be able to recognize errors in good time and, if necessary, to remedy them.
  • the manufacturers of the measuring systems offer control liquids that are specific to each measuring system.
  • the control liquids usually consist essentially of aqueous, buffered solutions of the analyte in a known, predetermined concentration.
  • control liquids are known, for example, from US Pat. No. 5,187,100 and US Pat. No. 5,605,837.
  • US 5,187,100 describes a control fluid that was designed for blood glucose measurement with the One-Touch TM system from Lifescan, Inc.
  • the One-Touch TM system is an optical measuring system based on a two-wavelength measurement at 635 nm and 700 nm consisting of a measuring device and test strips.
  • the control fluid from US Pat. No. 5,187,100 essentially mimics the flow properties of whole blood, for which purpose it is designed as a two-phase dispersion of deformable, non-water-soluble polymer particles in water to which a predetermined content of glucose has been added.
  • a dye copper phthalocyanine tetrasulfonic acid tetrasodium salt
  • offset adjuster for the control fluid from US Pat.
  • the document does not address the fact that it may be important to differentiate between sample and control liquids on the device side. Rather, the control fluid described aims to minimize the differences between the sample and control fluid.
  • US 5,605,837 describes control fluids intended for use with the Lifescan, Inc. SURESTEP TM system.
  • the SURESTEP TM system is also an optical two-wavelength measuring system consisting of measuring device and test strips for blood glucose measurements, which detects at 660 nm and 940 nm. While the increase in dye formation on the test strip is detected at 660 nm in the presence of glucose in the sample liquid, the measurement at 940 nm serves to check the presence of blood on the test strip in sufficient quantity. In order to ensure the latter function also for the control liquid, this is stained with opaque particles, for example carbon or iron oxide, so that absorption can be observed at 940 nm. This document also does not describe a procedure for how a measuring device can automatically distinguish between sample and control liquid.
  • EP-A 0 800 086 (Bayer) describes control liquids for electrochemical measuring systems which allow the control liquid to be recognized on the device and to be distinguished from a sample; In this case, measurement values that originate from the determination of a control liquid are preferably not transferred to the measurement value memory.
  • EP-A 0 800 086 proposes an algorithm which takes into account the dynamic current profile of sample and control liquid measurements. However, this method cannot be applied to measuring systems other than electrochemical ones (such as photometric systems). Furthermore, the distinction described in EP 8 00 086 assumes that a relationship is formed between a "read current" and a "burn current".
  • the object of the present invention was to eliminate the disadvantages of the prior art.
  • the invention relates to a method for automatically distinguishing between a sample liquid and a control liquid with the aid of an analytical measuring system, which detects a special property of the control liquid or the automatic differentiation takes place on the basis of at least two criteria which relate to the property of the sample liquid or the control liquid detected by the measuring system ,
  • test elements also known synonymously as test strips
  • measuring device The quality and / or functional control of an analytical system, which consists of test elements (also known synonymously as test strips) and measuring device, is intended to ensure that measurement results obtained during a measurement with the analytical system are always correct, accurate and repeatable.
  • test elements also known synonymously as test strips
  • measuring device In particular for medical diagnostics, which should give the doctor indications of targeted therapy, these are essential prerequisites to reliably rule out incorrect diagnoses or therapies.
  • the analytical measuring system contains test elements and associated measuring devices.
  • the measuring system preferably comprises test elements to be evaluated photometrically (often also referred to synonymously as test strips or test device) and a photometer.
  • the measuring system detects and evaluates an optically detectable property of the sample or control liquid, e.g. B. absorption, transmission, reflectance, fluorescence or phosphorescence and the like.
  • the measuring system comprises test elements to be evaluated electrochemically (often also referred to as test strips, test devices or sensors) and an electrochemical measuring instrument. Electrochemical properties that are recorded and evaluated with such systems include voltages (for example in potentiometry), currents (for example in amperometry or voltammetry), charges (for example in coulometry) and the like more.
  • Test elements in the sense of the invention include reagents specific to one or more analytes in a detection system. If the analyte is present in the sample liquid, the detection system leads to a signal that can be detected by the measuring device of the measuring system, for example caused by a color formation or a characteristic current. Suitable test elements and detection systems are known to the person skilled in the art in a large number of embodiments.
  • the detection system can contain an enzyme, an electron transmitter and an indicator dye.
  • the method according to the invention essentially uses an aqueous solution of the target analyte, for example glucose, cholesterol or lactate, as control liquids.
  • the target analyte is preferably present in the solution in a predetermined, known concentration.
  • Common additives such as buffer substances, stabilizers, inorganic salts and the like can be added to this solution.
  • the additives it is only important to ensure that the desired detection reaction of the test strip is not influenced, in particular not negatively, by it.
  • the additives must have no influence on the color development of the indicator substance. The same applies to electrochemical detection systems or enzymatic reactions that take place on the test strip.
  • the automatic distinction between sample and control liquids takes place on the basis of a special property of the control liquid which the sample liquid does not have or in another form.
  • This can be an optical or electrochemically detectable property, in particular absorption, remission or conductivity (e.g. different salt loading of the control solution compared to the sample liquid), or flow behavior (e.g. aqueous control solution can fill a capillary faster than a blood sample).
  • This special property is preferably caused by a substance added to the control liquid, which preferably does not occur in the sample liquid.
  • a dye is added to the control liquid. It is particularly preferred that the added dye is an IR dye which has no essential absorption in the wavelength range in which the measurement signal is determined for the analysis determination. Dyes which absorb in the near infrared range (so-called IR dyes) have proven to be particularly suitable according to the invention. For example, the following classes of compounds have been found to be suitable: metal complexes of quinoline quinones, nickel dithiolene dyes, nickel tetramine dyes, quinone dyes, phthalocyanine dyes, naphthocyanine dyes, special azo dyes (cf. M. Matsuoka, Infrared absorbing dyes, Plenum Press, New York, 1990).
  • IR dye ST 1651 (2- [2- [2-chloro-3 - [[l, 3-dihydro-l, l-dimethyl-3 - (4-sulfobutyl) -2H-benz [ e] indol-2-ylidene] - 1 -cyclopenten-1-yl] ethenyl] -1,1-dimethyl-3- (4-sulfobutyl) -lH-benz [e] indolium, inner salt, sodium salt), for example available from SYNTHON Chemie GmbH & Co. KG, Wolfen, Germany.
  • the substance added to the control liquid is electrochemically active.
  • the added substance is an electrolyte (e.g. sodium chloride etc.) which significantly changes the conductivity of the control solution with respect to blood, plasma, serum or other body fluids.
  • the greatly increased conductivity of the control solutions compared to isotonic body fluids serves to differentiate (control sample / measurement solution) in the measuring device. For example, on the basis of the conductivity limit values specified for the device, a corresponding display is triggered or an entry is made in the measured value memory which identifies the measurement as a measurement of a control solution.
  • a substance is added to the control solution which is electrochemically inactive, ie which has no influence on the measurement signal and only serves to delay the flow properties of the control solution (for example preferably in a test device capillary).
  • the filling time of the measuring solution entering the capillary is determined by means of two-point measurement (e.g. via the conductivity or impedance). If the time exceeds the pre for physiological solutions (blood, plasma, serum, cerebrospinal fluid, etc.) it is a control solution that is recognized and identified as such by the measuring device.
  • Preferred additives are thickeners (for example derivatives of alginic acid; cellulose derivatives; swelling agents).
  • the substance added to the control liquid does not influence the detection system of the analytical measurement system.
  • the measurement of the control fluid with the analytical measuring system serves to control the properties of the measuring system and the detection system.
  • the control fluid usually contains a known amount of analyte. This amount is determined using the detection system.
  • the presence of additional substances in the control liquid must not change the reactions in the detection system or the processes in the measuring system in such a way that different measurement results are obtained with the same analyte concentrations in the sample liquid and in the control liquid.
  • the substance or the substances that are added to the control liquid used according to the invention in order to allow identification of the control liquid may not or not significantly intervene in the actual measurement process according to the invention.
  • electrochemical measuring systems it must be ensured that the added substance cannot interfere with the electrochemical measuring process due to its redox properties.
  • the redox potential of the added substance must not be such that it is converted to the electrodes when the detection voltage is applied to an amperometric sensor system and leads to a current flow.
  • the general statements made above for additives also apply to the substances added with regard to influencing the detection reactions.
  • a method is preferred in which the criteria for distinguishing between sample and control liquids are based on the different wetting behavior of the control liquid and sample liquid.
  • a method is particularly preferred in which the rate of wetting is used as a criterion for distinguishing between sample liquid and control liquid.
  • Second embodiment In the context of the present invention, a distinction is also proposed, in which two criteria are used to differentiate between samples and control fluid.
  • a corresponding method according to the second embodiment can be carried out without the presence of a property of the control liquid which the sample liquid does not have. Rather, the distinction is made on the basis of different characteristics of a common property.
  • a distinction can also be used for differentiation, which the sample liquid does not have or in another form. According to the description of the first embodiment, this additional property can be generated by adding substances to the control liquid.
  • Example 1 Based on Example 1, it is very particularly preferred according to the invention that a control solution containing an IR dye is used in a test system containing photometric test elements and a photometer, and blood is used as the sample liquid, and a absorption or remission in the IR is used -Area measures.
  • a control solution containing an electrochemically active additive is used, and blood is used as the sample liquid, and the electrochemical measuring device distinguishes the control solution from the sample liquid by distinguishing it respective conductivities or viscosities recorded. It was also found here that the measurement signal of a control liquid approaches an end value faster than with sample liquid and that the end value is more constant. According to these observations, a method is proposed in which, after the sample or control liquid has been applied, the time course of the measured values is recorded and evaluated to determine how quickly the measured value approaches an end value and how constant the end value is.
  • Figure 1 shows typical waveforms.
  • an initial range can be identified in which there is a sudden, strong change in the signal and an end range with essentially constant measured values that represent an end value.
  • the time range in which a certain signal swing occurs and the associated range can be recognized as the start range can be determined.
  • the end point or an end region can also be identified with a termination criterion. Possible termination criteria are, for example, a signal change by less than a predefined difference value or a plurality of measured values which fluctuate less than a predefined value by an average value.
  • the time period belonging to the initial range or the speed of a signal change can be used as a first criterion.
  • the second criterion can be the fluctuation of measured values in the end area or the temporal change of measured values in the end area.
  • the fluctuation can be determined, for example, by summing deviations from an average or by determining the standard deviation.
  • a short starting range and a high constancy of the measured values in the end range are particularly pronounced if the measured values are determined on the basis of a special property of the control liquid, for example by an added substance.
  • the concentration of this substance is preferably essentially constant during the measurement.
  • control liquid which is suitable for use in the method according to the invention.
  • control liquid advantageously contains an electrochemically active substance and / or a dye, the substance and / or dye not influencing the detection system of the measuring system. It is particularly preferred that the control liquid contains an IR dye as described above.
  • Blood samples and control fluids were remission photometry at 880 nm, measured using photometric blood glucose test strips Accu-Chek ® Compact from Roche Diagnostics GmbH, Mannheim, Germany. The remissions were measured in 0.2 s steps.
  • the measured value difference between wetted and non-wetted test field must be 25% or more (expressed in relative remission, "rel. Rem.”), And at the same time 2.) the measured value difference of the fully wetted test field for the immediately following measuring cycle 7% rel. Rem. Or less.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Materials By The Use Of Chemical Reactions (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

L'invention concerne un procédé permettant de différencier automatiquement une solution à examiner d'une solution témoin, en particulier en relation avec des systèmes de mesure analytiques. Selon ce procédé, la différenciation s'effectue sur la base de la présence d'une propriété spécifique de la solution témoin et/ou d'au moins deux critères. L'invention concerne également des solutions témoins correspondantes adaptées à ce nouveau procédé.
EP03761487A 2002-06-29 2003-06-24 Differenciation automatique d'une solution a examiner et d'une solution temoin Withdrawn EP1520171A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE10229314 2002-06-29
DE10229314A DE10229314A1 (de) 2002-06-29 2002-06-29 Automatische Unterscheidung von Proben- und Kontrollflüssigkeit
PCT/EP2003/006613 WO2004003549A2 (fr) 2002-06-29 2003-06-24 Differenciation automatique d'une solution a examiner et d'une solution temoin

Publications (1)

Publication Number Publication Date
EP1520171A2 true EP1520171A2 (fr) 2005-04-06

Family

ID=29796020

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03761487A Withdrawn EP1520171A2 (fr) 2002-06-29 2003-06-24 Differenciation automatique d'une solution a examiner et d'une solution temoin

Country Status (7)

Country Link
US (2) US7670846B2 (fr)
EP (1) EP1520171A2 (fr)
JP (1) JP4056524B2 (fr)
AU (1) AU2003242747A1 (fr)
CA (1) CA2487336A1 (fr)
DE (1) DE10229314A1 (fr)
WO (1) WO2004003549A2 (fr)

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US20070235346A1 (en) * 2006-04-11 2007-10-11 Popovich Natasha D System and methods for providing corrected analyte concentration measurements
US7909983B2 (en) * 2006-05-04 2011-03-22 Nipro Diagnostics, Inc. System and methods for automatically recognizing a control solution
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US20120165696A1 (en) * 2009-06-03 2012-06-28 Martijn Wilco Arns Method for assessing the susceptibility of a human individual suffering from a psychiatric or neurological disorder to neuromodulation treatment
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BR112017011033B1 (pt) * 2014-12-19 2021-12-14 F. Hoffmann-La Roche Ag Sistema para determinar pelo menos uma propriedade de uma amostra e método para determinar pelo menos uma propriedade de uma amostra
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Also Published As

Publication number Publication date
WO2004003549A2 (fr) 2004-01-08
CA2487336A1 (fr) 2004-01-08
US7670846B2 (en) 2010-03-02
US20100144042A1 (en) 2010-06-10
AU2003242747A1 (en) 2004-01-19
DE10229314A1 (de) 2004-01-29
JP4056524B2 (ja) 2008-03-05
AU2003242747A8 (en) 2004-01-19
JP2005531760A (ja) 2005-10-20
US20050244981A1 (en) 2005-11-03
WO2004003549A3 (fr) 2004-04-22

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